Kornimate/medical-research-clean huggingface dataset:
high risk breast clinic: protocol for women at increased risk for developing breast cancer

Conditions: Breast Cancer

Summary: the overall goal of this project is to develop an integrative system of breast cancer risk assessment based on epidemiologic and biologic risk variables, as well as to develop or refine risk biomarkers which may be useful in predicting and monitoring response to prevention interventions.

1. to correlate established risk biomarkers such as cytomorphology obtained from random periareolar fine needle aspiration ( rpfna), mammographic breast density, serum bioavailable estradiol and igf-1/igfbp-3 with each other and with 5-10 year gail risk estimates. where available, and with appropriate safe guards to maintain status for breast cancer susceptibility genes may be included. 2. to determine the relative predictive value of established risk biomarkers for the development of dcis and/or invasive cancer. 3. to evaluate potential new breast tissue-based biomarkers including ki-67, pcna, er, cox-2, aromatase, methylation of key tumor suppressor genes (i.e., rar, p16, etc), proteomic patterns in rpfna and nipple aspirate fluid (naf), as well as naf hormone levels, and correlate them with other risk biomarkers listed in 1. 4. to determine the prevalence of polymorphisms of a panel of genes important in hormone and xenobiotic metabolism as well as dna repair and correlate these polymorphisms with established risk biomarkers listed in 1, as well as with development of dcis and invasive cancer. 5. to maintain contact with this initially identified cohort of high risk women, acquire demographic data, biologic specimens and data and follow them prospectively for the development.

Eligibility criteria:
inclusion criteria: * women with at least 2 times the normal risk of developing breast cancer * between the ages of 30-65 (or within 10 years of youngest age at diagnosis in first degree relative) * greater than six months from ingestion of antihormonal therapy * greater than 1 year from pregnancy, lactation, or chemotherapy * willing to have a mammogram within six months prior to rpfna * willing to discontinue nsaids or herbal supplements * willing to have blood drawn exclusion criteria: * no metastatic malignancy of any kind * no breast implants or tram flap reconstructions * no radiation to both breasts * no women who have a current mammogram or clinical breast exam suspicious for cancer

Keywords: breast atypia fine needle aspiration high risk for breast cancer breast epithelial hyperplasia
whole-process quality improvement of endovascular treatment basd on an ai-aided clinical feedback system

Conditions: Stroke, Acute

Summary: a clustered randomized control trial to evaluate whether multi-aspect intervention based on an ai-aided clinical feedback system could improve the quality of evt and functional outcome of patients.

endovascular treatment (evt) is the standard treatment for acute ischemic stroke (ais) caused by large vessel occlusion (lvo) according to current guidelines. however, while a rapidly-growing number of stroke centers become capable of performing evt, the general quality of evt remains unsatisfied, resulting in a considerable proportion of patients who could not reach functional independence. our pre-established artificial intelligence (ai)-aided clinical feedback system could dynamically record and report key timepoints of evt in-hospital process. combined with multi-aspect intervention via remote/on-site surveillance and education, this may be a potential solution for quality improvement of evt. therefore, the aim of the study is to evaluate whether an ai-aided clinical feedback system coupled with multi-aspect intervention could improve the quality of evt. twenty hospitals with annual evt cases \> 30 will be 1:1 randomized into intervention group and control group. the intervention group will receive ai-based clinical feedback system coupled with multi-aspect intervention, including remote/on-site surveillance and education regarding in-hospital workflow and surgical procedures of evt. the control group only deploys ai-aided clinical feedback system. the primary outcome is the ratio of good functional outcome (mrs \> 2) at 3 month.

Eligibility criteria:
inclusion criteria: * age \> 18 * ais patients receiving evt within 24 hours of stroke onset * written informed consent is obtained exclusion criteria: * patients refuse to participate in this study
can musculoskeletal ultrasound predict fall risk in rheumatoid arthritis patients?

Conditions: Rheumatoid Arthritis

Summary: rheumatoid patients have higher fall risk than normal population. several fall risk factors were studied. no previous study investigated the role of musculoskeletal ultrasound as a predictor of fall risk in rheumatoid arthritis.

adults with rheumatoid arthritis are exposed to higher risk of fracture. risk factors included joint tenderness, fatigue, muscle weakness, impaired balance and disease activity. musculoskeletal ultrasound is a bed side radiographic tool that gained much attention in the last decade.it can detect stuctural chnges in the musculoskeletal system even before beeing detected by the x ray. nowadays, musculoskeletal ultrasound is a very useful tool in examining rheumatoid patients. no previous study was done to investigate the role of musculoskeletal ultrasound as a predicting factor of fall risk in rheumatoid patients. predicting the fall risk in such disease could help setting preventing measures to prevent falls with its sequels.

Eligibility criteria:
inclusion criteria: * adults with rheumatoid arthritis. exclusion criteria: * patients aged \< 18 years * patients with lower limb disability preventing the participant from performing the mobility tests, * patients who were using antidepressants and sedatives. * patients with severe comorbidities, severe vision impairment, or hearing loss or neurological diseases that interferes with the mobility as stroke or neuropathy, were also excluded.

Keywords: rheumatoid arthritis foot problems fall risk predictors
epidural analgesia use in pancreatic resections

Conditions: Cancer of Pancreas; Cancer of the Pancreas; Pancreas Cancer; Pancreas Neoplasms; Pancreatic Cancer

Summary: the rationale for this study is to investigate the benefits of epidural analgesia in pancreatic resections in a prospective, single blind, randomized control trial. this study will evaluate both short and long-term outcomes related to epidural analgesia, providing a longitudinal and comprehensive perspective to the advantages and disadvantages of this technique. the investigators hypothesize that the use of epidural analgesia reduces a patient's consumption of morphine or morphine-equivalent in the post-operative period following pancreatic resections.


Eligibility criteria:
inclusion criteria: * undergoing pancreatic resection. * age ≥18 years old. * able to understand and sign an institutional review board (irb)-approved informed consent form. exclusion criteria: * indication for operative intervention being chronic pancreatitis. * currently on warfarin with an inr≥1.4 or clopidogrel that cannot be discontinued 7 days prior to surgery; * most recent inr prior to surgery \>1.4 * most recent platelet count prior to surgery \<70,000/mcl * chronic opioid use as defined by use of more than 20mg oxycodone, or equivalent, daily. * history of pre-existing neuropathic pain conditions. * not giving consent for study participation. * known medical history of significant psychiatric or cognitive impairment * history of hiv, hepatitis b, and/or hepatitis c
eoe rct fluticasone and omeprazole vs fluticasone alone

Conditions: Eosinophilic Esophagitis

Summary: the purpose of this study is to evaluate the efficacy of combination therapy with omeprazole and swallowed fluticasone vs fluticasone therapy and placebo in the treatment of eosinophilic esophagitis (eoe) in children and adults. this study will be a double-blinded, randomized controlled trial. the primary outcome measured will be histologic assessment of esophageal tissue biopsies measuring number of eosinophils per high power field (eos/hpf). secondary outcomes will be endoscopic findings and symptomatic changes following therapy using validated endoscopic scoring measures and participant surveys, respectively.

subjects that meet study inclusion criteria will be recruited from the adult and pediatric gastroenterology clinics at walter reed national military medical center through routine clinic visits, will meet with an investigator, and complete informed consent/assent. the participants will then complete a validated clinical symptom reporting tool - the eosinophilic esophagitis symptom activity index (eesai) for age 18 and above, or the pediatric quality of life inventory (pedsql) for age 6-17yrs - and have their initial esophagogastroduodenoscopy (egd) images evaluated via a validated endoscopic reference score (erefs). esophageal biopsies taken at the patient's initial egd will be assessed by 2 designated blinded pathologists to record the number of eosinophils per high power field (hpf), as well as perform tissue immunohistochemical staining for eotaxin-3. participants will be block randomized to treatment or control groups and complete 8 weeks of therapy, with a phone follow up at 4 weeks for medication compliance. at the completion of 8 weeks of therapy, the participants will have repeat egd to assess for mucosal healing, which is the standard of care in the treatment of eoe. at this egd, the images will be assigned an erefs and the biopsies will be evaluated for eosinophils per high powered field and eotaxin-3 staining. the patient will also complete an eesai or pedsql. this procedure will end the 8 week study period.

Eligibility criteria:
inclusion criteria: * age 6 to 60 years old * deers (defense enrollment eligibility reporting system) eligible * diagnosis of eosinophilic esophagitis exclusion criteria: * outside of age range * co-existing inflammatory gastroenterologic condition such as celiac disease, eosinophilic esophagitis, or inflammatory bowel disease. * concurrent use of oral steroids * pregnancy * refusal to undergo endoscopy
effectiveness of bubble nasal continuous positive airway pressure (bcpap) in neonatal respiratory distress

Conditions: Neonatal Respiratory Distress

Summary: the objective of study is to determine the effectiveness of bubble continuous positive airway pressure (bcpap) in neonates presenting with respiratory distress as compared to the control group ( using oxygen via nasal cannula). the effectiveness will be calculated in terms of reduction in silverman anderson retraction score.

after approval from the irb of king edward medical university, and taking informed consent from parents of the participants, total of 120 neonates fulfilling inclusion and exclusion criteria will be enrolled and randomly allocated in two groups; group a and group b. all demographic details of participants in both groups be collected. in group a, neonates will be given bcpap for respiratory support while neonates in group b, will be given nasal oxygen as control group. neonates in both groups will be followed for 48 hours. the effectiveness will be determined by the reduction in silverman anderson retraction score (sars) up to or less than 3, at the end of 48 hours. data will be collected and analysed.

Eligibility criteria:
inclusion criteria: * patients having age 28 days of life or younger (neonates) * gender- both male and female * gestational ages ≥32 weeks * having respiratory distress (as per the operational definition- respiratory rate \>60/min plus any of the following features: grunting, subcostal/intercostal retractions, nasal flaring, inability to maintain spo2 \>90% at room air) * silverman anderson retraction score ≥4 exclusion criteria: * neonates having gestational age less than 32 weeks * birth weight less than 1.5 kg * neonates having congenital malformations, air leak syndromes, hypoxic ischemic encephalopathy * neonates requiring mechanical ventilation at the time of admission

Keywords: bubble cpap respiratory distress neonates silverman anderson retraction score
leveraging transdermal alcohol monitoring to reduce drinking among dwi defendants

Conditions: Drunk Driving

Summary: the current study will evaluate the efficacy of contingency management (i.e., reinforcement for avoiding heavy drinking) among adults arrested for drunk driving and who are at risk for ongoing heavy drinking.

individuals who have a drunk driving arrest and are at risk for ongoing heavy drinking will be recruited to test the efficacy of contingency management for reducing alcohol use and identifying mechanisms of change. we will recruit those arrested for drunk driving offenses, ≥ 21 years of age, who at risk for ongoing heavy alcohol use and randomize them to one of two groups: control or a contingency management. participants experience 8 weekly assessments of current alcohol use and other variables associated with changes in alcohol use. post-intervention, participants will return to the laboratory once per month at 3, 6, 9, and 12 months post-study entry for follow-up procedures to determine the mechanisms of drinking behavior change.

Eligibility criteria:
inclusion criteria: * arrested for drunk driving offense exclusion criteria: * significant alcohol withdrawal symptoms * medical condition that would contraindicate participation (e.g., pregnancy, scheduled surgery) * inability to comprehend the informed consent process or study instructions * presence of a dsm-5 psychiatric disorder with symptoms of psychosis and/or delirium * incarceration

Keywords: alcohol impaired driving driving while intoxicated driving under the influence driving while impaired
study of oral lbh589 in patients with cutaneous t-cell lymphoma and adult t-cell leukemia/lymphoma

Conditions: Cutaneous T-Cell Lymphoma; Leukemia-Lymphoma, Adult T-Cell

Summary: this study will assess the safety, efficacy and pharmacokinetics of oral lbh589 in japanese adult patients with refractory cutaneous t-cell lymphoma and adult t-cell leukemia/lymphoma. lbh589 is administered orally once a day for three days per week.


Eligibility criteria:
inclusion criteria: * ctcl: biopsy-confirmed mf or ss stages ib-iva2. * patients who have ss with bone marrow involvement are also eligible. * patients with transformed ctcl are eligible. * atl: patient with cytologically or histopathologically confirmed lymphoma. * lymphoma should be identified as tumors derived peripheral t-cells by cell surface marker. * atl: patients with positivity for anti-htlv-1 antibody * patients must have received at least two systemic therapy regimens. * patients must have had disease progression on or following their most recent treatment regimen. * age ≥ 20 years * ecog performance status of ≤ 2 * written informed consent obtained prior to any study specific screening procedures exclusion criteria: * patients with a history of primary cns tumors * any history or presence of brain metastases * patients with any peripheral neuropathy ≥ ctcae grade 2 * patients with unresolved diarrhea \> ctcae grade 1 * impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of oral lbh589 * patients with concurrent severe and/or uncontrolled liver or renal disease * patients using sodium valproate ≤5 days prior to starting study drug * patients with an active bleeding diathesis or on any treatment with therapeutic doses of sodium warfarin or other antivitamin k drugs * patients who have received any investigational drug or chemotherapy or undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy * patients who have received biologic therapy, target therapy (e.g. denileukin diftitix ), vaccine, systemic steroids or immunotherapy ≤ 2 weeks prior to starting study treatment or who have not recovered from side effects of such therapy * patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy

Keywords: lbh589 hdac inhibitor cutaneous t-ceii lymphoma adult t-cell leukemia
a post-approval registry for exablate 4000 type 1.0 and type 1.1 for unilateral pallidotomy for the treatment of advanced, idiopathic parkinson's disease with medication-refractory moderate to severe motor complications

Conditions: Movement Disorders; Neurology; Parkinsons Disease

Summary: this registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years. the proposed registry will enroll 60 subjects and will be conducted at approximately 10 centers worldwide.

this is a post-approval registry which is required by of the approval under pma p150038/s014 for the exablate® model 4000 (exablate neuro) type 1.0 and type 1.1 for unilateral pallidotomy in the treatment of idiopathic parkinson's disease with medication-refractory moderate to severe motor complications. subjects participating in this registry will have received a unilateral pallidotomy using the commercially available exablate neuro. the following assessments will be collected at baseline, 3, 6, and 12 months post exablate procedure and annually thereafter for 5 years: adverse events (aes) (does not apply to baseline visit) medication usage mds-updrs unified dyskinesia rating scale eq-5d-5l wpai-gh clinician and patient global impression of change patient satisfaction questionnaire

Eligibility criteria:
inclusion criteria: * men and women, age 30 years and older. * subject undergoing a planned an exablate procedure for their parkinson's disease with motor complications per local institution standard of care. * subject is willing to cooperate with the registry requirements including compliance with the regimen and completion of all registry visits. * subject has signed and received a copy of the approved informed consent form. exclusion criteria: * subject does not agree to participate or is unlikely to participate for the entirety of the registry.
rifaximin vs placebo for the prevention of encephalopathy in patients treated by tips

Conditions: Cirrhosis

Summary: tips has been used for 20 years, as a means of reducing portal pressure in patients with cirrhosis and portal hypertension related complications. tips proved more effective than alternative treatments in controlling or preventing variceal bleeding and refractory ascites. the main drawback of the tips procedure is progressive overt hepatic encephalopathy (ohe). three risk factors for post-tips ohe have been identified: age over 65 years, history of previous episodes of ohe, and child-pugh score equal to or over 10. however, the incidence of post-tips ohe in patients fulfilling these criteria remains close to 35 %.

tips has been used for 20 years, as a means of reducing portal pressure in patients with cirrhosis and portal hypertension related complications. tips proved more effective than alternative treatments in controlling or preventing variceal bleeding and refractory ascites. the main drawback of the tips procedure is progressive overt hepatic encephalopathy (ohe). three risk factors for post-tips ohe have been identified: age over 65 years, history of previous episodes of ohe, and child-pugh score equal to or over 10. however, the incidence of post-tips ohe in patients fulfilling these criteria remains close to 35 %. furthermore, the pathogenesis of he in general but also in patients treated by tips is still not well understood. therefore, there is a real challenge in discovering new molecular mechanisms involved in pathogenesis of ohe as well as new treatment to better prevent the risk of ohe in patients treated by tips. observational and experimental studies suggest a microbiota's role in the mechanism of ohe and recently a non absorbable antibiotic has proven to reduce the risk of recurrence of ohe. however, the effect of this drug for the prevention of a first episode of ohe in patients treated by tips is not known. in addition, the mechanisms of the beneficial effect of rifaximin remain poorly understood.

Eligibility criteria:
inclusion criteria: * cirrhosis with tips for ascit treatment or hydrothorax * prevention digestive bleeding follow up portal hypertension - * signed consent exclusion criteria: * hepatocellular carcinoma out of milan criteria or palliative phase cancer * child pugh score \> 12 * tips indicated for other indication than bellow * encephalopathy signs : asterixis or confusion * hypersensibility to rifaximin, or derivated of rifamycin * patients treated by same class antibacterial * pregnant woman * patient with hepatic transplant

Keywords: tips portal pressure rifaximin overt hepatic encephalopathy microbiota
bowel function after minimally invasive hysterectomy

Conditions: Constipation

Summary: postoperative constipation affects up to a third of women undergoing minimally invasive (mis) gynecologic surgery and is a major source of anxiety and discomfort. the average time to first bowel movement after gynecologic surgery is about 2 to 4 days and some factors responsible for this include anesthesia inhibitory effect on gastrointestinal motility, opioid pain medication use, chronic nsaid use and anatomic manipulation. there are no established regimens to manage postoperative constipation after minimally invasive gynecologic surgery. two studies evaluating the implementation of postoperative bowel regimen with polyethylene glycol (peg) and with senna and docusate found no significant impact on postoperative bowel function. there have been no studies looking at the effect of preoperative bowel regimens on postoperative bowel function. the purpose of this study is to evaluate postoperative bowel function after minimally invasive hysterectomy in women receiving a preoperative 10-day bowel regimen of peg daily.

following enrollment subjects will be randomized into the intervention/treatment arm and control arm. all subjects will be asked to complete a baseline demographic form and three questionnaires (pac-sym, pac- qol, wexner constipation score). additional demographic information will be obtained from chart review. this information will include past medical history, use of constipating medications, use of daily pain medications, chronic pain history, use of daily fiber supplementation. subjects in the intervention arm will be given 10-day supply of miralax and instructed on its use. they will take this medication for the 10 days prior to surgery. subjects in the control arm will continue with standard care prior to surgery. post operatively, all subjects will complete a diary for 7 days. in this diary they will record details about their bowel movements (time of movement, discomfort, texture of stool). they will also report average daily pain levels ( with a visual analog scale), daily pain medication use (time, medication, total number of pills). at the end of the 7th day all subjects will complete the same pac questionnaires as they did pre-operatively.

Eligibility criteria:
inclusion criteria: * any woman ≥ 18 years of age undergoing a minimally invasive hysterectomy (laparoscopic, robotic, vaginal) * able to understand the consenting process and willing to participate in study exclusion criteria: * planned laparotomy * emergent surgery * regular preoperative use of peg 3350, laxatives, enemas or suppositories * planned bowel surgery * presence of colostomy * inability to consent * medical problems as follows: * ckd (cr: \> 1.2 mg/dl) * iddm * cardiac disease * gastric ulcers * difficulty swallowing or esophageal stricture * persistent nausea or vomiting * signs or symptoms of a small bowel obstruction